Measuring Normal Esophageal Flexibility in Children Using EndoFLIP (EndoFLIP)
Prospective Measurement of Normative Esophageal Distensibility Using EndoFLIP in Asymptomatic Children
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared device that measures the size, pressure, and flexibility (distensibility) of the esophagus. In adults, EndoFLIP measurements are routinely used to evaluate esophageal motility disorders such as achalasia. However, normal reference values for children have not been established, and pediatric interpretation currently relies largely on adult data.
The purpose of this prospective, single-center observational study is to generate preliminary normative pediatric EndoFLIP measurements. One hundred children between 5 and younger than 18 years of age who are undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia will be enrolled. Eligible participants must have no history of esophageal disease or surgery and no symptoms suggestive of upper gastrointestinal disease.
Immediately before the scheduled colonoscopy and motility catheter placement, an EndoFLIP catheter will be inserted through the mouth and positioned across the lower esophageal sphincter. Measurements of esophageal diameter, cross-sectional area, pressure, compliance, and distensibility index will be obtained at standardized balloon fill volumes (20-60 mL). The EndoFLIP assessment requires approximately 3-5 minutes and does not require an upper endoscopy or any additional anesthesia. After the measurements are completed, the catheter is removed and the planned clinical procedure proceeds as scheduled. No additional study visits or follow-up are required.
The primary objective is to establish preliminary normative pediatric values for esophageal distensibility and related biomechanical parameters. Secondary analyses will evaluate associations between EndoFLIP measurements and participant age, height, weight, and body mass index. These data are intended to improve interpretation of pediatric EndoFLIP studies and support future research and clinical care for children with esophageal disorders.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Population étudiée
La description
Inclusion Criteria:
- Age 5 to <18 years
- Scheduled to undergo clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia
- No upper gastrointestinal symptoms (including dysphagia, recurrent vomiting, gastroesophageal reflux, or odynophagia)
- No history of esophageal disease or esophageal surgery
- Parent/guardian consent and participant assent, when applicable
Exclusion Criteria:
- Known or suspected esophageal pathology
- Prior esophageal surgery or instrumentation
- Anatomic upper gastrointestinal abnormalities
- Contraindication to anesthesia or EndoFLIP catheter placement
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Asymptomatic Children Undergoing EndoFLIP Assessment
Children 5 to younger than 18 years of age undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia who have no history or symptoms of esophageal disease.
Participants undergo a single 3-5 minute EndoFLIP assessment before the scheduled procedure to measure esophageal distensibility index, diameter, cross-sectional area, compliance, and pressure for development of preliminary normative pediatric reference values.
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The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared impedance planimetry device used to measure esophageal diameter, cross-sectional area, intraballoon pressure, distensibility index, and compliance.
In this study, the EndoFLIP catheter is inserted orally during general anesthesia immediately before clinically indicated colonoscopy with colonic motility catheter placement.
Measurements are obtained over approximately 3-5 minutes at standardized balloon fill volumes of 20-60 mL, after which the catheter is removed and the planned clinical procedure proceeds.
The EndoFLIP assessment is performed solely for research purposes to establish preliminary normative pediatric esophageal biomechanical reference values.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Esophageal Distensibility
Délai: During the procedure (approximately 3-5 minutes)
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Esophageal distensibility index measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Esophageal Diameter
Délai: During the procedure (approximately 3-5 minutes)
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Esophageal diameter measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Esophageal Cross-sectional Area
Délai: During the procedure (approximately 3-5 minutes)
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Esophageal cross-sectional area measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Esophageal Compliance
Délai: During the procedure (approximately 3-5 minutes)
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Esophageal compliance measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Intraballoon Pressure
Délai: During the procedure (approximately 3-5 minutes)
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Intraballoon pressure measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 28226
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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